Cleared Traditional

K211649 - PCEA Syringe Set

K211649 is an FDA 510(k) clearance for PCEA Syringe Set, manufactured by Baxter Healthcare Corporation. The device is a Class 2 General Hospital device with product code PWH cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K211649 · Baxter Healthcare Corporation · General Hospital
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Nov 2021
Decision
179d
Days
Class 2
Risk

K211649 is an FDA 510(k) clearance for the PCEA Syringe Set. Classified as Administrations Sets With Neuraxial Connectors (product code PWH), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on November 23, 2021 after a review of 179 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K211649

510(k) Number K211649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2021
Decision Date November 23, 2021
Days to Decision 179 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 129d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PWH Device Classification - Class 2, Special Controls

Product Code PWH Administrations Sets With Neuraxial Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
Definition The Connector For Neuraxial Applications Is Intended To Facilitate Ansi/aami/iso 80369-6:2016 Compliant Neuraxial Specific Connections.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.